Description

n-(2,6-Dimethylphenyl)-2-(Ethylmethylamino)Acetamide Hydrochloride (Lidocaine Impurity E) is a high-purity reference standard and pharmaceutical impurity critical for quality control in drug development and manufacturing. This compound is essential for ensuring the safety and efficacy of lidocaine-based pharmaceutical products by enabling accurate identification and quantification of process-related impurities. It is primarily used by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Lidocaine Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in developing and validating chromatographic methods (HPLC, GC) for impurity profiling in lidocaine and related anesthetic compounds.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B) for impurities.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in lidocaine formulations under various storage conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval processes.
• Research & Development: Used in synthetic chemistry research to study the formation, isolation, and properties of lidocaine-related impurities.

Basic Information

Item	Information
Product Name	n-(2,6-Dimethylphenyl)-2-(Ethylmethylamino)Acetamide Hydrochloride (Lidocaine Impurity E)
CAS No.	50295-20-0
Molecular Formula	C13H20N2O · HCl
Molecular Weight	256.77 g/mol
Synonyms	Lidocaine Impurity E; Lidocaine EP Impurity E; Lidocaine Related Compound E; 2-(Ethylmethylamino)-N-(2,6-dimethylphenyl)acetamide hydrochloride; N-(2,6-Dimethylphenyl)-2-(N-ethyl-N-methylamino)acetamide hydrochloride; Diethylaminoacet-2,6-xylidide Impurity; Xylocaine Impurity E
EINECS	Contact for details

Quality Control

Our n-(2,6-Dimethylphenyl)-2-(Ethylmethylamino)Acetamide Hydrochloride is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified parameters and relevant guidelines (ICH, USP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.